BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFINE

    MDR report key: 8537225 · Received April 22, 2019

    Report

    Report Number
    3011617315-2019-00001
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 19, 2019
    Manufacturer
    FACET TECHNOLOGIES LLC
    Product Code
    FMI
    PMA / PMN Number
    K140568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER STATED THAT NEEDLE CAME OUT OF HUB AND BECAME LODGED IN HER STOMACH. HER PHYSICIAN REQUESTED THAT SHE GO TO THE HOSPITAL FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330810 CAREFINE PEN NEEDLE FMI FACET TECHNOLOGIES LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention